Enanta Announces U.S. FDA Approval Of AbbVie's MAVYRET™ (glecaprevir/pibrentasvir) For The Treatment Of Chronic Hepatitis C In All Major Genotypes (GT1-6) In As Little As 8 Weeks

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration (FDA) approved AbbVie's MAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVYRET is an 8-week, pan-genotypic treatment for patients without cirrhosis and new to treatment. Up to 95 percent of HCV patients in the U.S. may be eligible for treatment with MAVYRET, including patients with compensated cirrhosis or without cirrhosis, and those with limited treatment options, such as patients with chronic kidney disease (CKD).*

Following this approval of MAVYRET in the U.S., Enanta expects to receive a $40 million milestone payment from AbbVie.

"A majority of the estimated 3.4 million Americans chronically infected with HCV have not yet been treated for the disease and do not yet have cirrhosis. The FDA approval of MAVYRET provides them a new, 8-week treatment option regardless of their HCV genotype," stated Jay R. Luly, Ph.D., President and CEO, Enanta. "Our second protease inhibitor, glecaprevir, is part of this new combination treatment that has now been approved in the E.U. and the U.S."

Approximately 3.4 million Americans are chronically infected with HCV. 1 Additionally, HCV is common among people with severe CKD, with more than 500,000 # people in the U.S. estimated to have both chronic HCV and CKD. 2 MAVYRET was designed to deliver a cure** across all major genotypes and for specific treatment challenges, such as patients with severe CKD, and GT1 patients not cured by a NS5A inhibitor or a NS3/4A protease inhibitor (PI) in a direct-acting antiviral (DAA) treatment, but not both. MAVYRET combines two new DAAs that target and inhibit proteins essential for the replication of the hepatitis C virus.

The approval of MAVYRET is supported by data from nine registrational studies in AbbVie's clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations.

If you liked this article you might like

Strong On High Relative Volume: Enanta Pharmaceuticals (ENTA)

Insider Trading Alert - ENTA, EBIO And PSEC Traded By Insiders

5 Hated Stocks You Should Love

Insider Trading Alert - ENTA, HBI And MOFG Traded By Insiders

Enanta Pharmaceuticals (ENTA) Showing Signs Of Perilous Reversal Today